Counting mechanism

ABSTRACT

A counting mechanism (100) for a dispenser comprising: a first and a second housing part (110, 120) that are rotatable relative to each other; and a counting ring (130) disposed between the housing parts. The first housing part has a protrusion (111) which abuts the counting ring, holding a portion of the counting ring in contact with the second housing part. The relative rotation of the housing parts causes the protrusion to slide against the surface of the counting ring to drive a rolling movement of the counting ring around the circumference of the second housing part, such that a predefined rotation of the housing parts produces an incremental rotational displacement between the counting ring and second housing part to record a count. The counting mechanism provides a large gear reduction ratio in a compact form which is straightforward to manufacture and provides an accurate and reliable record of counts.

RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 16/310,255, filed 14 Dec. 2018, which is a national stageapplication under 35 U.S.C. § 371 of International Application No.PCT/GB2017/051724, filed 14 Jun. 2017, which claims priority to GreatBritain Patent Application No. 1610450.7, filed 15 Jun. 2016. The abovereferenced applications are hereby incorporated by reference into thepresent application in their entirety.

TECHNICAL FIELD

The present invention relates to a counting mechanism, in particular acounting mechanism for a dispenser or sampler wherein the mechanism mayrecord the number of dispensing counts or sampling counts.

BACKGROUND

Counting mechanisms and devices are well known in the art and take manydifferent forms with the common aim of providing means to incrementallycount a number of events. Such mechanisms are often incorporated intosamplers to record a count of sampling events and dispensers to record acount of dispensing events. A particularly important application ofcounting mechanisms within dispensers is in medical devices where theycan provide a record of the number of doses dispensed and remaining.

Medical devices such as inhalers, nasal sprays and injection pens areall used to deliver medication to a patient. These devices often containmultiple doses and can be used by a patient over several days or weeks.As the devices reach a near empty state, the device may emit a dose thatis less than the label claim. Frequently this loss of dose is notvisible to the user and therefore may result in an insufficient dosebeing delivered with possible implications for the effective treatmentof a related condition.

It is therefore desirable for users to keep track of the number of dosesthat they have administered, to ensure that they are neither underdosing(leading to a lack of efficacy) nor overdosing (with potential sideeffects and complications). For these reasons it is desirable to includea counting mechanism in the device that indicates the number of dosesremaining in the device, and that locks out to prevent the device beingused once a certain number of doses have been used.

An ideal counter has a number of requirements. It must be robust andreliable and should accurately count doses regardless of how the useruses the device. It should only count when a dose has actually beendelivered and it should not be possible to back track or rewind thecounter and it should not lose or gain counts when dropped. The countershould also be easy to read, preferably with colouring, such that userscan clearly see the number of doses remaining at a glance. Lastly, itshould be low cost and easy to manufacture. Many counters in devicessuch as pMDIs (pressurised metered dose inhalers) contain a large numberof parts in order to achieve the previous functions. This increases thecost and means such devices are more liable to malfunction throughfailure of one of the many components.

A large number of counters have been disclosed in the prior art, forexample U.S. Pat. No. 6,651,844 discloses counters for nasal sprays andU.S. Pat. No. 9,022,039 discloses counters for simulated cigarettes.However, primarily counters have been disclosed for inhalers as severalregulatory authorities have mandatory requirements for such devices.

In particular a wide range of counting mechanisms have been proposed tobe used with pMDIs including mechanisms with ratchet and pawl mechanisms(US2002139812), face gears (U.S. Pat. No. 8,740,014), kick wheels (U.S.Pat. No. 8,820,318), escapement mechanisms (US2002195102) and helicaltracked teeth (US20060231093). pMDI counters have a challenging set ofrequirements in that they must accurately keep track of the very smallreciprocating movement of the actuator stem and translate this motioninto a small count. As a result these counters are often very complexconsisting of multiple parts and mechanisms so that they are insensitiveto manufacturing tolerances.

However, there are fewer counters disclosed in the prior art that arefor devices actuated using a large rotational movement, whereby thelarge rotational movement must be geared down into a much smallermovement of a counter wheel. U.S. Pat. No. 6,769,601 discloses a counterfor a DPI (dry powder inhaler) which converts the rotation motion of ametering drum into small counts using a large geared wheel and ratchet.Although large gear reductions can be achieved with a wheel and ratchet,the counter wheel must be substantially larger than the metering drum inorder to achieve the right resolution which inhibits such a mechanismbeing provided in a compact and user friendly device.

The counter disclosed in U.S. Pat. No. 6,149,054 comprises a spindle andtooth mechanism. An indicator flag, which is threaded onto the spindlemoves upwards as the spindle is turned, indicating the count. Thecounter can achieve large gear reductions (60:1) and is low cost,however the resolution of the counter is limited by the length of thespindle which means that it is difficult to identify individual counts.Furthermore, the spindle requires a long, fine thread which is difficultto accurately mould with implications on the cost of manufacturing thedevice.

WO02006062448 discloses a counting mechanism containing an indicatorstrip, preferably metal, arranged around a rotatable feed wheel. Thespacing of numbers on the feed wheel can be controlled so that a largenumber of doses can be displaced per rotation. However this requires asubstantial amount of tape as there is no gear reduction, thereforehaving implications for the ease of manufacture and the extent to whichthe mechanism can be incorporated in a compact, user friendly device.

U.S. Pat. No. 8,181,645 discloses a counter for a DPI which contains twocounter rings where the first (units counter ring) is driven by theindexing of the device using a large Geneva wheel and the second counterring (tens) is driven via the first counter ring via a Geneva mechanism.The Geneva mechanism is used to convert the large continuous rotation ofthe counter ring into the intermittent rotation of the tens counterring. In order to achieve the large (120:1) gear reductions necessary todisplay all of the doses, the described patent has to have multiple gearreduction stages with the consequent additional parts, additionalbacklash and additional tolerance sensitivity.

There accordingly exists a need for a counter which is capable of largegear reductions whilst being compact such that it can be combined in auser friendly device with a small form factor. There is a further needfor the counting mechanism to be formed from a minimum of constituentparts to increase the ease of manufacture and assembly while keepingassociated costs down. The counter should record counts accurately andreliably whilst being robust to wear such that the counter may be usedover the lifetime of the device in which it is employed. Finally thereexists a need to provide means for the device to automatically lockafter a certain number of counts such that, when employed in a dispenserfor example, the number of doses dispensed is limited.

SUMMARY OF THE INVENTION

The present invention seeks to provide a counting mechanism which can beemployed in a dispenser or sampler which solves the above describedproblems of prior art devices. Importantly the present invention seeksto provide a counter which can achieve large gear reductions such that alarge rotational movement of the device—for example to provide thesampling or dispensing function—can be geared down to provide a smallincremental movement which records a count. A further aim of theinvention it to provide the large gear reductions with a minimum ofcomplex parts in a mechanism which is robust, low cost, easy toassemble, records counts accurately and has a small form factor. Thepresent invention further seeks to provide a lock out mechanism for acounting mechanism which can lock the count mechanism after a certainnumber of counts. Importantly the lock out mechanism should be reliablebut formed from a minimum of parts to reduce the manufacturing andassembly costs.

According to a first aspect of the invention, there is provided acounting mechanism for a dispenser or a sampler comprising: a firsthousing part and a second housing part, wherein the housing parts arerotatable with respect to each other and the second housing part has acurved cross-sectional shape; a counting ring disposed between the firstand second housing parts; the first housing part having a protrusionwhich abuts the counting ring, holding a portion of the counting ring incontact with the second housing part; wherein relative rotation of thehousing parts causes the protrusion to slide against the surface of thecounting ring to drive a rolling movement of the counting ring aroundthe circumference of the second housing part; such that a predefinedrotation of the housing parts produces an incremental rotationaldisplacement between the counting ring and second housing part to recorda count.

With the counting mechanism according to the present invention, arotation of the housing parts is geared down to provide a smallincremental rotation between the counting ring and one of the housingparts. In this way, a large rotation of the housing parts, for exampleto provide a dispensing or sampling function, is recorded by the muchsmaller incremental rotational displacement between the counting ringand second housing part, thus providing the required large gearreduction in a compact form.

The counting mechanism according to the present invention only requiresthree parts and therefore is low cost and easy to manufacture andassemble. The mechanism allows for a large number of rotations of thehousing parts to be recorded whilst maintaining a small form factor fora user friendly device. The mechanism according to the present inventionis furthermore highly accurate and has very little backlash.

Since the incremental movement of the counting ring is via rollingmovement, there is very little wear, making the device more robust tofailure of these components, prolonging the lifetime of the device. Therolling movement also provides quiet operation, increasing the userfriendliness of the device.

According to a second aspect of the present invention there is provideda lock out mechanism for a counting device, the counting devicecomprising: a first housing part; a second housing part rotatable withrespect to the first housing part; and a rotatable counting part;wherein rotation of the counting part is driven by rotation of thesecond housing part such that a full rotation of the second housing partproduces an incremental rotation of the counting part with respect tothe first housing part; the lock out mechanism comprising: a lockingfeature provided on each of: the counting part, the first housing partand the second housing part, the features configured to lock togetherwhen all simultaneously aligned; wherein the locking feature of thesecond housing part and the locking feature of the counting part areeach arranged so as to align with the locking feature of the firsthousing part once every full rotation of the corresponding part; suchthat after a sufficient number of rotations of the second housing part,all three locking features are driven into alignment, triggering thelock out.

With the lock out mechanism according to the present invention, arotatable three part counting mechanism (wherein one of the parts isdriven by rotation of the others) may be prevented from further rotationonce a predefined number of counts are recorded. The lock out mechanismutilises the fact that the three parts only align once during thelifetime of the device and therefore simultaneous alignment may be usedto initialise lockout. The simplicity of the mechanism means it isstraightforward and low cost to manufacture and the possibility offailure is reduced. The possibility of introducing a sprung featurewhich is driven orthogonally to the direction of rotation means theparts are tightly locked and cannot be easily overcome by applying aforce to rotate the housing parts.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments of the invention will now be described, by way of exampleonly, with reference to the accompanying drawings, in which:

FIGS. 1A and 1B schematically illustrate an exploded view and a crosssection of a first example of a counting mechanism according to thepresent invention;

FIGS. 2A and 2B schematically illustrate a front view and a crosssection of the first example of a counting mechanism according to thepresent invention;

FIGS. 3A to 3D schematically illustrate various alternative forms thatthe optional gear teeth of the counting mechanism may take;

FIG. 4 schematically illustrates the assembly of the first housing partand counting ring of a counting mechanism according to the presentinvention;

FIGS. 5A to 5E schematically illustrate various alternative forms thatthe protrusion of the first housing part may take;

FIGS. 6A and 6B schematically illustrate an exploded view and a crosssection of a second example of a counting mechanism according to thepresent invention;

FIGS. 6C and 6D schematically illustrate a front view and a crosssection of the second example of a counting mechanism according to thepresent invention;

FIGS. 7A and 7B schematically illustrate a front view and a crosssection of the third example of a counting mechanism according to thepresent invention;

FIGS. 8A to 8F schematically illustrate a cross sectional view of afourth example of a counting mechanism according to the presentinvention and various alternatives for the constituent parts;

FIGS. 9A and 9B schematically illustrate an exploded and assembled viewof a fifth example of a counting mechanism according to the presentinvention;

FIGS. 10A to 10F schematically illustrate various alternatives for theconstituent parts of the examples of the present invention;

FIGS. 11A to 11D schematically illustrate the principle of operation ofthe lockout mechanism for a counting mechanism according to the presentinvention; and

FIG. 12A to 12C schematically illustrate an example of a lockoutmechanism employed in a first example of the counting mechanismaccording to the present invention.

DETAILED DESCRIPTION

FIGS. 1A and 1B schematically illustrate a counting mechanism 100according to the present invention. The counting mechanism 100 comprisesa first housing part 110 and a second housing part 120. The secondhousing part 120 has a curved cross-sectional shape and is rotatablerelative to the first housing part 110. The counting mechanism 100further comprises a counting ring 130 which is positioned between thefirst 110 and second 120 housing parts. The first housing part 110 has aprotrusion 111, shown in the exploded view of FIG. 1A which ispositioned so as to abut the counting ring 130 when the mechanism 100 isassembled.

When assembled the protrusion acts so as to hold the counting ring 130against the second housing part 120. When the housing parts 110, 120 arerotated the protrusion slides against the surface 131 of the countingring 130 which drives a rolling movement of the counting ring 130 aroundthe circumference of an opposing curved surface of the second housingpart 120. In this way, a predefined rotation of the housing parts 110,120 produces an incremental rotational displacement between the countingring 130 and second housing part 120. The number of incrementalrotational displacements between the counting ring 130 and secondhousing part 120 therefore provides a record of the number of predefinedrotations of the housing parts.

Cycloidal Mechanism

In the example of FIG. 1, the first housing part, the second housingpart and the counting ring each have a substantially cylindrical shape.The counting ring 130 has a radius such that, when the device isassembled by bringing the parts together along the axial direction F-F,the counting ring 130 fits over a portion 112 of the first housing partand lies within the second housing part 120. The second housing part 120substantially encloses the counting ring 130 and at least a portion 112of the first housing part, as illustrated in FIG. 2A.

The interaction between the housing parts 110, 120 and the counting ringis best illustrated by the cross-section G-G shown in FIG. 2B. In thisexample, once assembled, the housing parts 110 and 120 are substantiallycoaxial, with a portion of the first housing part 110 lying within thesecond housing part 120 such that they are substantially concentric asshown in FIG. 2B. The counting ring 130 is positioned between theoverlapping portions of the first and second housing parts, and isdisplaced off-axis by the contact of the radially extending protrusion111 of the first housing part 110. Therefore, when assembled, thehousing parts 110, 120 share a common axis of rotation, shown as F-F inFIG. 1A, and the counting ring 130 is eccentrically positioned,displaced from this axis. As shown in FIG. 2B the protrusion 111 extendsoutwards radially from the first housing part 110 to abut the innersurface of the counting ring 130 and hold a portion of the outer surfaceof the counting ring 130 in contact with the inner surface of the secondhousing part 120. In this example the counting ring 130 is thereforeeccentrically positioned with respect to the housing parts 110, 120. Thediameter of the counting ring is such that, when assembled with aportion of the counting ring 130 in contact with the second housing part120 at a first position 141 adjacent to the protrusion 111, the countingring is separated from inner surface of the second housing part 120 at asecond position 142 corresponding to the opposite side of the firsthousing part to the protrusion 111.

The first housing part 110 may have one or more additional radialprotrusions 111 a circumferentially separated from the first 111 by 90degrees. The additional protrusions 111 a are smaller than the first111, such that they do not extend far enough radially to produce contactbetween the counting ring 130 and second housing part 120. Instead, theprotrusions 111 a may help in adding further stability to the countingring, aiding in holding it in the correct eccentric position shown inFIG. 2B.

When the first housing part 110 is rotated about axis F-F with respectto the second housing part 120, the protrusion 111 slides against theinner surface of the counting ring as the first housing part rotateswithin the counting ring 130. The portion 141 of the counting ring heldin contact with the inner surface 121 of the second housing part 120therefore moves with the protrusion, such that the counting ring rollsaround the inner circumference of the second, outer housing part 120.Since the circumference of the outer surface of the counting ring 130 issmaller than the circumference of the inner surface 121 of the secondhousing part 120, a full clockwise rotation of the first housing partwill produce an incremental anticlockwise displacement of the countingring 130 relative to the second housing part 120, provided the countingring 130 rolls against the inner surface of the second housing partwithout slipping. The counting ring 130 and opposing surface 121 of thesecond housing part 120 therefore provide the gears, configured toproduce the reduction in rotational motion of the counting ring 130relative to the housing parts.

In order to facilitate the rolling movement of the eccentrically mountedcounting ring 130 around the circumference of the inner surface 121 ofthe second housing part and to substantially prevent slipping, themechanism may further preferably comprise two opposing arrays of gearteeth 122, 132. As shown in FIG. 2B an array of teeth 132,122 isprovided both around the circumference of the outer surface of thecounting ring 130 and the opposing inner surface of the second housingpart 120. The eccentric displacement of the counting ring 130 by theprotrusion 111 therefore causes the opposing gear teeth to mesh at thecontacting portion 141 of the counting ring 130 and second housing part120. The diameter of the counting ring 130 may be such that there is aseparation between the opposing gear teeth at a position 142 on the sideof the mechanism opposite that of the protrusion 111. As the firsthousing part 110 rotates, the position of the meshed gear teeth movesaround the housing, driven by the sliding contact of the protrusion onthe inner surface of the counting ring 130. The rolling movement of thecounting ring 130 against the surface of the second housing part istherefore provided by a sequential interlocking of the gear teeth aroundthe inner circumference of the second housing part 120.

The interlocking gear teeth 122, 132 prevent the counting ring 130 fromslipping relative to the surface 121 of the second housing part 120since the position of the counting ring is restricted to the positionsin which the teeth mesh. Relatedly, the gear teeth 122, 132 also definethe rotational displacement between the counting ring 130 and secondhousing part 120 provided by a rotation of the first housing part 110relative to the second housing part 120. For example, if the differencein circumferences of the inner surface of the second housing part 120and the outer surface of the counting ring 130 is accounted for byproviding one extra tooth on the array of gear teeth 122 on the secondhousing part, a full rotation of the housing parts will produce arotational displacement equivalent to the separation between consecutiveteeth. This can be pictured from the diagram of FIG. 2B where a fullclockwise rotation of the first housing part 110 relative to the secondhousing part 120 will cause the counting ring 130 to move anticlockwiserelative to the second housing part 120 by a distance corresponding toone tooth.

The cycloidal gearing system provided by the example of presentinvention illustrated in FIGS. 1 and 2 allows for a very high gearingratio to be provided in a compact form since, unlike conventionalgearing mechanisms, the highest gearing ratios are provided when the twogears have a similar number of teeth rather than greatly differingnumbers of teeth. The components can therefore be of a similar size andbe integrated in a compact form. The gearing reduction ratio provided bythis type of gearing mechanism used in this example of the presentinvention may be calculated by

${{Reduction}\mspace{14mu} {Ratio}} = \frac{{{Inner}\mspace{14mu} {teeth}} - {{Outer}\mspace{14mu} {teeth}}}{{Inner}\mspace{14mu} {teeth}}$

Therefore, when applied in a dispenser, in order to provide a 35:1gearing ratio the inner gear could have 35 teeth and the outer 36.

For a toothed cycloidal gear, the maximum single-stage gear reductionwhich can be achieved is therefore equal to the number of inner teethwhich can be fitted on the part. The number of teeth which can fit alonga given length is limited by part tolerances and the potential forclashes in the mechanism.

Furthermore, the rotational motion of the counting ring is continuousand can therefore be used to measure fractions of a revolution—this isuseful because a dispensing or sampling device may be designed todispense multiple doses per revolution. For example, a counter with a35:1 gearing could be used to count 70 doses, if a single dose wasdispensed every 180° turn of the first housing, relative to the secondhousing.

The example of FIG. 2 uses a cycloidal tooth profile, as shown enlargedin FIG. 3A. A cycloidal tooth profile provides a strong connectionbetween the counting ring and second housing part. This shaped profilealso reduces interference in the non-meshed portions. Since the profilerolls rather than slides over the opposing teeth and the teeth have aconvex flank, wear is minimised and operation is quiet. The highstrength and low wearing make cycloidal teeth preferable for use in thecurrent invention, however several other tooth shapes may equally beused. FIG. 3B illustrates a further option in the form of an involutetooth profile. This tooth profile shape is formed of a single curve anda flat and therefore is economic to machine. Involute gear teeth alsoprovide a constant pressure angle throughout rotation and rotate at aconstant velocity irrespective of the gear centring. FIGS. 3C and 3Dshow a 35 saw-tooth counting ring and a 70 saw-tooth counting ringrespectively. Since the saw-tooth shape has steeper tapering towards theend of the tooth, the probability of clashing is lowered. In a preferredembodiment cycloidal teeth are used due to the low wear, but where highgearing ratios are preferred (for instance on a 70:1 counter) asaw-tooth may be preferable, because clashes become more likely as thenumber of teeth increases and the steeper tapering of this shape helpsto mitigate this effect.

As described above, since rotation of the housing parts causes a muchslower rotation of the counting ring 130 relative to the second housingpart 120, the rotational displacement of the counting ring 130 mayprovide a count of the number of rotations of the housing parts (andtherefore a count of the number of doses dispensed in the case of adispenser or sampling events in the case of a sampler). In order tocommunicate the count information to a user, a scale 133 may be providedon the mechanism to provide a visual indication of the rotationaldisplacement between the counting ring 130 and second housing part 120.FIG. 4 is an illustration of the first housing part 110 and countingring 130 which shows a possible scale 133 provided on the counting ring130. This may be created by printing or the application of a label forexample with gradations and colours providing a visual indication of thenumber of doses remaining. For instance, amber may be used to make theuser aware that they should order another device and red to indicatethat there is less than one week of dose remaining. Additionally numbersmay be added to provide an exact number of doses remaining. The scale133 may be combined with a window 123 on the second housing part 120such that only a portion of the scale 133, corresponding to the currentnumber of rotations, is visible to the user. Since this rotationaldisplacement between the second housing part and counting ring providesthe count, the scale features—the scale 133 and window 123 in thiscase—should be provided on these components to together provide a recordof counts.

To ensure the mechanism cannot be driven in the reversedirection—corresponding to an anti-clockwise rotation of the firsthousing part 110 in FIG. 2B—the mechanism may additionally include aratchet feature 124 and a pawl feature 114. In the example of FIG. 1Athe ratchet 124 is provided around the internal surface of the secondhousing part 120 and the pawl 114 is provided on the first housing part110.

In the exemplary mechanism of FIGS. 1 to 4, the protrusion 111 is awedge feature which protrudes radially from the first housing part inorder to provide the eccentric displacement of the counting ring andrequired contact with the second housing part. This may additionally besupplemented by smaller wedge or semi-circular protrusions 111 acircumferentially offset from the first—in this example by 90°. Three ormore contact points on the inner surface 131 of the counting ring 130work together to hold the counting ring in the correct eccentricposition such that the opposing teeth 122, 132 of the counting ring 130and second housing part 120 mesh at the contact point 141 adjacent tothe main protrusion 111. There are several alternative forms the radialprotrusion 111 may take, as illustrated in FIGS. 5A to 5E. In place ofthe small wedge features shown in FIG. 5A, the radial protrusion 111 maytake the form of a pear shaped cam formed on the outer surface of thefirst housing part as illustrated in FIG. 5B. Alternatively, the radialprotrusion may be provided by the body of the first housing part havinga cross-sectional shape defined by an eccentrically centred circle, asillustrated in FIG. 5C. In this case the eccentricity is provided by thenon-uniformity in the cross-section of the housing part.

Alternatively to the above described rigid features, the protrusion mayalternatively take the form of a sprung feature. FIGS. 5D and 5E show alower housing part 110 in which the protrusion 111 is provided by amoulded spring and a leaf spring respectively. The addition of a springfeature increases the complexity of manufacture compared to the aboveintegrally formed examples, however a sprung feature ensures a positiveengagement force at all times and helps to alleviate any tolerancestacks within the mechanism. This spring feature could be formed inmoulded plastic on one of the housing or counting parts, or it could bea separate part altogether. Although having a separate spring part wouldcomplicate assembly and add cost, it allows metal springs to be used,which have desirable material properties for springs, such as energystored per unit volume.

In the above described examples, the counting ring 130 is provided by arigid part, for example manufactured from rigid plastic. This is so thatthe force applied by the protrusion 111 acts to displace the countingring 130 off-axis without it deforming or substantially changing shapein any way. However, rather than comprising a rigid part, the countingring 130 could alternatively be a flexible belt. Example materials forthis belt could be an elastomer, for instance: silicone, EPDM, TPE, TPUor Viton; a polymer, typically with low modulus, such as a polyolefin,or a reticulated or very thin section of an engineering polymer ormetal. The flexible belt may be advantageous because it largelyeliminates issues with teeth 122, 132 clashing. The gearing ratioachievable is limited by the number of teeth on the counting ring andsecond housing part, and the number of teeth (for a given volume) islimited by how small those teeth can be made. The minimum size of teethis dictated by achievable tolerances—gears where teeth are out oftolerance will clash and jam. If a flexible material is used for thecounting ring 130, then it is unable to support compressive load and itwill simply deform instead. Because compressive loads cannot besupported, the counter cannot jam, and this decreases the minimum viabletooth size for the mechanism, which means many teeth can be fittedwithin a small volume. However, the primary disadvantage of a beltdriven system is that the position of the unmeshed portion of the beltis unknown—this makes a belt unsuitable for communicating countinformation to the user. This issue could also be corrected by usingadditional features or parts, such as constructing a counting ring 130with living hinges between a driven belt and a more rigid countindicator. There is a continuum between a substantially rigid counterwhich maintains the shape of the unmeshed section, but suffers fromclashing and a flexible counter which does not hold its shape but doesnot suffer from clashing. A semi-rigid polymer counter may offer a goodcompromise between accuracy and sensitivity to clashing, for a specificcounter.

Additionally, the counting mechanism may include features on thecounting ring 130 or housing parts 110, 120 which trigger functions atcertain points during the lifetime of the device. For example once afeature on the incrementally rotating counting ring 130 has reached acertain rotational displacement a signal or light may be displayed to auser or, if employed in a dispenser, the volume of dose dispensed maychange.

An important example of a function triggered in this way may be lockoutof the device triggered at the end of the lifetime (as indicated by acertain rotational displacement of the counting ring). For example thedevice may have an end of life lockout which triggers after 70 doses.This may be achieved by having a slot on the counter, a slot on thelower housing and a sprung member on the upper housing, which only alignonce 70 doses (for example) have been dispensed. The sprung member isdriven into the slots orthogonally to the direction of rotation of thehousings. This effectively locks the upper housing, lower housing andcounting ring together, preventing the user from dispensing more doses.

The lockout mechanism is described in more detail below.

The counting functionality is not dependant solely on a lockout or acount indication to the user; it may also be used for collecting data tosend to a third party.

Multi-Stage Mechanism

Although the examples described above use a single counting ring 130 torecord counts, to achieve very large gearing ratios in a compact size, amulti-stage mechanism can be used. In terms of gearing ratio, addingfurther stages scales geometrically, whereas adding more teeth scalesadditively, so eventually it will always be preferable to add furtherstages, rather than add more teeth. An advantage to the mechanismaccording to this invention is that a second stage can be added withonly a single extra part. Further stages after the second can also beadded with only a single extra part each.

A two-stage embodiment of this counter which can be used to achieve verylarge reduction ratios is to have a second counting ring, which islargely the same as the upper housing, except it has one more (or less)internal tooth. In this example, every full rotation of the firsthousing part relative to the second housing part offsets the firstcounting ring from the upper housing by one tooth (1st stage) and everyfull rotation of the counting ring offsets the second counting ring andthe outer housing off by one tooth (2nd stage). For the above describedmechanism this would give a gearing ratio for the first stage of 35:1and a gearing ratio for the second stage of 36:1, giving a total gearingratio of 1260:1 in a counter which only requires four parts, two ofwhich are formed by housing parts 110, 120.

Further stages can be added by placing a protrusion on the free surfaceof the second stage and using this to drive a further cycloidal gear.Since the second stage forms the driving component (first housing partequivalent) and the fixed reference (upper housing) can be sharedbetween all stages—a third stage is comprised of a second counting ringand a fourth stage can be added in the same manner as the second. Thiscan be repeated such that a mechanism with n stages only requires n+2parts (or n extra parts once discounting the housings)

A multi-stage mechanism may be particularly advantageous forapplications which need a very large gearing ratio in a small diameter.The diameter of the geared parts is essentially proportional to thenumber of teeth they contain, so larger gearing ratios require largerdiameters. By instead stacking gears, a mechanism could maintain a smalldiameter at the cost vertical space. This form factor is particularlyuseful for long thin products, such as parenteral drug delivery devicesor e-cigarettes.

Inverse Cycloidal Mechanism

FIGS. 6A to 6D show a further example of a counting mechanism accordingto the present invention. This example is similar to the cycloidalmechanism examples described above and employs the same operatingprinciples but the housing parts 110, 120 have the “inverse”functionality. In particular, the upper, outer housing part acts as thefirst housing part 110 which drives the counting ring 130 and the inner,lower housing part acts as the second housing part 120 against which theincremental rotation of the counting ring 130 is measured.

In this example, the counting ring 130 lies around the second (lower)housing part 120 and within the first (upper) housing part. The radialprotrusion 111 extends inwardly from the smooth inner surface of thefirst (upper) housing part to contact the outer surface of the countingring 130. The contact of the protrusion 111 on the counting ring shiftsthe counting ring off-axis such that the inner surface 131 is held incontact with the outer-facing surface 125 of the second (lower) housingpart 120. The counting ring 130 of this example has a circumferentialarray of teeth 132 running around the inside surface of the countingring 130. The second housing part has an opposing array of teeth 122which run around the circumference of the outer facing surface of theportion 125 of the second housing part 120 on which the counting ring130 lies. The contact of the radial protrusion 111 with the countingring 130 therefore causes the opposing teeth 122, 132 to mesh at aposition 141 adjacent to the protrusion 111, as shown in FIG. 6D.

In this example, utilising the inverse operation to the cycloidalarrangement described above, the operation of the device is bestunderstood by considering the second (lower) housing part 120 as fixed,with the first (upper) housing part rotating. As the first housing part110 is rotated with respect to the second housing part 120, theprotrusion 111 slides against the outer surface 135 of the counting ring130, causing the inner surface of the counting ring 130 to roll againstthe outer surface of the second housing part 120. The meshed contactportion 141, shown in FIG. 6D, therefore propagates around the interfaceof the counting ring 130 and second housing part 120, the rollingmovement facilitated by a sequential interlocking of the opposing gearteeth 122, 132.

In this inverse arrangement, the counting ring 130 has more teeth thanthe second housing part 120 such that, after a full rotation of thefirst housing part 110 relative to the second housing part 120, thecounting ring 130 will have moved forward relative to the second housingpart 120 by a rotational displacement corresponding to the difference innumber of teeth. The number of incremental rotational displacementsbetween the counting ring 130 and second housing part 120 (as measuredfrom a known starting point) therefore provides a record of the numberof rotations of the housing parts 110, 120.

Since in this inverse arrangement the counting motion is happeningbetween the lower (second) housing 120 and counting ring 130, it ispreferable to have any counting scale 133 or indication between thesetwo parts. The counting indication can take place between the upperhousing and the counting ring, but then it is preferable to cover thescale during the motion (and uncover after each full rotation forexample) otherwise the user might become confused as to how many countswere shown.

A disadvantage of the inverse mechanism when compared to the abovedescribed example is that because the teeth are formed at a smallerradius there is less room for teeth, which limits the maximum gearreduction available.

Friction-Based Mechanism

The central function of the gear teeth 122, 132 in the above embodimentsis to ensure that the movement of the counting ring 130 with the secondhousing part 120 is solely via a rolling contact and that there is noslipping of the surfaces against each other. Since the count ofrotations of the housing parts 110, 120 is provided by the fixed ratiobetween the amount of rotation of the housing parts and the inducedincremental displacement between the counting ring and second housingpart, any slip would disrupt this ratio (by producing more than just theincremental displacement) and therefore result in an inaccurate recordof counts. However the non-slip condition can equally be provided byalternative mechanisms other than the opposing arrays of teeth, as longas this condition can be achieved to an extent necessary to provide arequired accuracy.

FIGS. 7A and 7B illustrate one such mechanism which uses high frictionsurfaces 121, 135 rather than teeth to achieve the required non-slipcondition. In this example, the arrangement of the housing parts 110,120 and counting ring 130 are identical to that described with referenceto FIGS. 1 to 4. However instead of circumferential arrays of teethbeing provided around the opposing surfaces of the counting ring 130 andsecond housing part 120, these surfaces are configured to provide a highfriction contact, sufficient to provide the no slip condition.

In order to minimise slippage it is desirable to maximise both thecoefficient of friction and reaction force between the counting ring 130and second housing part 120. Reaction force can be maximised by using asprung part (as detailed previously), or by having materials whichelastically deform combined with an interference fit. Friction can bemaximised by surface treatment, texturing or using similar, highfriction materials, such as silicone or TPE. The use of TPE could beparticularly advantageous, because it could be over moulded or mouldedas part of a two shot process—rather than requiring a separate assemblystep.

An advantage of this mechanism is that removing the teeth completelyeliminates the possibility of clashes and ties the theoretical maximumgear ratio to the tolerances on the perimeter of the counting ring 130and the second housing part 120. As long as the non-slip condition canbe maintained and the user is able to read the scale with sufficientprecision given the small incremental movements, extremely high gearingratios are achievable. For example a counting ring with an outerperimeter of 100 mm and a second housing part 120 with an innerperimeter of 100.25 mm would give a gearing ratio of 400:1 in a singlestage.

The disadvantages of this mechanism include the possibility that thecounting ring may be more prone to slipping with only friction actingrather than a mechanical reaction force. Furthermore, since the gearingratio is determined by a continuous variable (ratio of perimeters)rather than a discrete one (the ratio of teeth) it is very tolerancesensitive. By way of illustration, if in the example above there was a±0.1 mm tolerance on the perimeter of each of the parts, then if theparts were within specification the gearing ratio could be anywherebetween 222:1 and 2002:1.

Harmonic Gear Mechanism

A further example of a counting mechanism according to the presentinvention is illustrated in FIG. 8A. Again, the principle of operationof this example is very similar to that described with reference toFIGS. 1 to 4. However in this case, rather than being mountedeccentrically, the counting ring 130 is flexible and is deformed tocontact the inner surface of the second housing part at certain pointsdue to the shape of the first housing part around which it ispositioned.

The arrangement of the housing parts 110, 120 and counting ring 130 issimilar to that shown in FIG. 1A, with the counting ring 130 positionedaround a portion 112 of the first housing part 110 and lying within thesecond housing part 120. However in this example, the radial protrusionsare provided by the cross-sectional shape of the portion 112 of thefirst housing part 110 around which the counting ring 130 is positioned.For example, in the example of FIG. 8A the cross section of the portion112 of the first housing part has an elliptical or rounded rectangularcross-section wherein the ends of the elongate axis of the ellipseprovide the radial protrusions 111. Since the counting ring 130 isflexible and the length of the elongate axis of the ellipticalcross-section is greater than the diameter of the relaxed counting ring130, the counting ring must deform when placed around the first housingpart 110. The cross-sectional shape of the first housing part portion112 is appropriately sized such that the deformation of the countingring 130 causes the counting ring 130 to contact the inner surface ofthe second housing part 120 at positions 141 corresponding to theprotrusions 111.

As with previous examples, two opposing circumferential arrays of gearteeth may be provided around the counting ring 130 and second housingpart 120 with a differing number of teeth provided on each component.The contact between the counting ring 130 and second housing part 120,imparted by the first housing part protrusions 111, therefore results inthe meshing of the opposing gear teeth at the contacted positions 141.

When the first housing part 110 is rotated relative to the secondhousing part 120, the rotation of the elliptical cross-section of thefirst housing part portion within the counting ring 130 causes theradial deformation of the counting ring 130 to propagate around thecircumference of the counting ring 130. The counting ring 130 thereforerolls against the opposing surface of the second housing part andproceeds via a sequential interlocking of teeth. A full rotation of thefirst housing part relative to the second housing part thereforeproduces the required incremental rotational displacement between thecounting ring and second housing part corresponding to the difference innumber of teeth.

A difference in the configuration of this example is that the firsthousing part provides at least two contact points 141 between thecounting ring 130 and second housing part 120. The example of FIG. 8Ahas two in-phase contact regions in which the teeth are meshed with tworegions 142 which are 90 degrees offset from these contact points 141.Because there are two points of contact 141, difference in the number ofteeth between the counting ring 130 and second housing part must beeven—which halves the achievable gearing ratio. An advantage of thisharmonic gear example is that the two points of contact allow forgreater load transmission before yield, although generally in countingapplications the loads transmitted are not significant.

Regarding the cross-sectional shape of the first housing part portion112 which drives the deformation, shapes with the same circumferentiallength as the flexible counting ring 130 can be chosen such that theydefine the position of all points on the counting ring by fittingtightly within it. Alternatively, shapes can be chosen which have acircumferential length which is smaller than the length of the countingring 130. For example the cross-sectional shape shown in FIG. 8B may beused to drive a counting ring which fits tightly around it or thecross-sectional shape of FIG. 8C may be used to drive the same lengthcounting ring which would leave portion of the counting ring undefinedon each of the elongate sides, due the smaller circumference. There isno danger of clashes between the “loose” portions of the counting ring130 and the teeth of the second housing part because the flexiblecounting ring 130 cannot support the compressive loads required tocreate a jam, provided teeth are meshed properly at each of the contactpoints.

Shapes which have a perimeter length less than that of the counting ringsuch that they do not fully define the counting ring's position can havemultiple different arrangements, depending on the lengths of thecounting ring portion between any two adjacent contact points. Thegearing down ratio is defined by the number of teeth on the countingring and therefore (for a given tooth pitch) the total length of thecounting ring used. In this way, assuming the counting rings of FIGS. 8Dand 8E have the same pitch of teeth and both have less teeth than thesecond housing part 120, the counting ring of FIG. 8D would provide thegreatest gearing down ratio due to its longer length (closer to that ofthe internal surface of the second housing part 120).

The number of separate regions 141 in phase is equal to the minimumdifference in the number of teeth between the two parts. For a fullydefined flexible counting ring, the difference in the number of teeth132 must be a multiple of the number of regions 141 in phase. Because ofthis, it may be advantageous to use a first housing part 110 with morethan two contact points, particularly if the number of contact pointsrequired is a prime number such as the first housing part of FIG. 8Fwhich has a cross-sectional shape defining seven protrusions 111.

It is also possible for the shape of the first housing part to provide“virtual” contact points. The shape of FIGS. 8D and 8E for example onlyhas two physical protrusions 111 offset from each other by 120 degrees.However this shape is equivalent to a shape with three protrusionsarranged at 120 degree intervals and therefore has a third, “virtual” inphase contact point. Therefore, for a fully defined case, the minimumdifference in the number of teeth between the two parts is three sincethe virtual in phase contact point is included in the total number.

Harmonic Face Gear Mechanism

FIGS. 9A and 9B illustrate a further example of a counting mechanismaccording to the present invention. This mechanism functions similarlyto the harmonic gear mechanism but in this example the contacting planebetween the counting ring 130 and second housing part 120 is parallel tothe direction of rotation of the housing parts 110, 120. As shown inFIG. 9A, an axial facing end face 136 of the counting ring 130 contactsan axial end face 126 of the second housing part and is held in place byprotrusions 111 on the first housing part 110.

As with the harmonic mechanism, in this example the counting ring 130 isflexible and can be deformed by contact with the protrusions 111 of thefirst housing part 110. As with the previously described examples, thefirst and second housing parts are substantially cylindrical with thediameters sized such that the first housing part 110 lies partiallywithin the second housing part 120 when the mechanism is assembled, asillustrated in FIG. 9B. The diameter of the counting ring 130 is largerthan that of the first housing part 110. One or more protrusions extendradially from the first housing part and an axial facing end of the oneor more protrusions contacts an axial face 137 of the counting ring,holding a corresponding portion 141 of the lower axial end face 136 ofthe counting ring 130 in contact with an opposing axial end face 126 ofthe second housing part 120. The protrusion 111 acts to deform thecounting ring, bending the contacted portion 141 out of the plane of thering to contact the opposing face 126 of the second housing part 120.

Rotation of the housing parts 110 and 120 therefore cause the protrusion111 to slide against the upper axial end face 137 of the counting ring,causing the deformation of the counting ring to propagatecircumferentially around counting ring 130 such that it rolls againstthe opposing end face 126 of the second housing part 120. Since thecounting ring 130 has a larger circumference than that of the secondhousing part, a full clockwise rotation of the first housing part 110shown in FIG. 9B, will cause an incremental clockwise rotationaldisplacement of the counting ring 130 with respect to the second housingpart. The number of incremental displacements from a known startingpoint therefore provides a record of the number of rotations of thehousing parts as with the other examples of the present invention.

The first housing part 110 may include further protrusions 111 b whichensure that other parts of the counting ring 130 remain separated fromthe second housing part 120. As shown in FIG. 9B, a series ofprotrusions 111, 111 b may be provided with the counting ring passingbelow certain protrusions 111 and above others 111 b. In this way, theprotrusions define the height of the counting ring at certain points,ensuring the counting ring only contacts the second housing parts at therequired point. Although in the example of FIG. 9, this function hasbeen performed by a series of protrusions which define the heights ofthe ring at certain points, it could also be performed by a combinationof protrusions (which define heights) and an outer cage which defines aradius which is smaller than the radius of the ring, causing it todeform.

However deformation is achieved, the first housing portion causes thecounting ring 130 to deform out of the contacting plane in such a waythat it matches the radius of the slightly smaller second housing part120. As with previous examples opposing arrays of teeth may be providedon the opposing faces of the counting ring and second housing parts suchthat the teeth mesh at the contacted portion (in-phase) and are inclearance at other points (anti-phase). The rolling motion is thenfacilitated by a sequential interlocking of teeth around thecircumference of the parts.

Further Alternatives

In the above embodiments the first 110 and second 120 housing parts arearranged coaxially such that they may be rotated relative to each otherabout a mutual axis of rotation. However this does not have to be thecase and in some devices it can be advantageous to have a non-coaxialcounter, such as if the geometric constraints imposed by the rest of thedevice mean that this can be more compact than the equivalent coaxialcounter.

A non-coaxial counter cannot have a rigid radial protrusion 111, becauseotherwise there are points of the rotation where the radial protrusionis either too small to force contact between the counting ring 130 thesecond housing part 120, or where it is too large and will cause jams.However, by using a compliant radial protrusion—for example a spring—theprotrusion 111 can adjust length to ensure that contact always takesplace. FIGS. 10A and 10B schematically illustrate the operation of amechanism which employs a sprung radial protrusion 111 to drive thecounting ring 130 in a non-coaxial arrangement of housing parts 110,120. FIGS. 10A and 10B shows that the rotational axis 143 of the secondhousing part 120 is offset from the rotational axis 144 of the firsthousing part 110. This accounted for by the compliant, sprung protrusion111 which is chosen so that it can apply a sufficient force to hold thecounting ring 130 against the second housing part 120 both on the sideclosest the axis 144 of the first housing part and the side furthestaway from the axis 144 of the first housing part—as illustratedrespectively in FIGS. 10A and 10B.

Similarly, although in the examples described above the housing partsare substantially cylindrical with a circular cross-section, othercross-sectional shapes can be used, particularly where the geometry ofthe rest of the device dictates that such shapes are more efficient thancircles. FIG. 10C illustrates a mechanism with a second housing part 120having an elliptical cross-section. Here again a compliant protrusion111 may be employed to account for the fact that the radius of thesecond housing part 120 varies so the protrusion must be able to apply asufficient force to hold the counting ring 130 in contact with thesecond housing part 120 for the complete rotation. Again, in the case ofFIG. 10C a spring is used for the protrusion 111 which compresses whensliding against the inside of the counting ring 130 past the minor axisof the ellipse and extends when rotating past the major axis of theellipse. In the latter case, although the force applied by the spring111 is reduced it is still sufficient to hold the counting ring 130against the second housing part 120 and provide the rolling contact.

Similarly the counting ring 130 does not need to be circular and theprotrusion 111 driving it can take any shape, provided the shapes of theparts are such that the counting ring is held in rolling contact withthe second housing part around the full circumference of the secondhousing part 120. An example is provided in FIG. 10D of an ellipticalcounting ring 130 being driven by an elongate protrusion 111, whichsatisfies this condition.

In general, the counting ring 130 and the second housing part 120 cantake any smoothly curved shape, provided that the radius of curvatureeverywhere on the outer gear (for example the second housing part 120 inthe examples of FIGS. 1 to 4 or the counting ring 130 in the example ofFIG. 6) is larger than the radius of curvature everywhere on the innergear (the counting ring 130 in the examples of FIGS. 1 to 4 or thesecond housing part 120 in the example of FIG. 6 for example)—ignoringsmall bumps, regions which do not mesh and the gear tooth profilesthemselves. FIGS. 10E and 10F illustrate examples of the cross-sectionalshape of the second housing part 120 which could satisfy thisrequirement. If the counting ring and second part are provided witharrays of teeth to provide the non-slip condition, the teeth must be thecorrect size and pitch to fit with the smaller gear having space to rollaround the inside of the larger.

The requirement to minimise the maximum radius of curvature for theinner gear means that a circle is the most preferable shape for an innergear, since this has the same radius of curvature at all points. So fora given size, a circle will always have the smallest maximum radius ofcurvature. By the same logic a circle is the most preferable shape foran outer gear: it has the same radius of curvature at all points, so fora given size, a circle will always have the largest minimum radius ofcurvature. Together, these statements mean that the greatest range ofpotential gearing ratios are achieved by using circles.

Lock Out Mechanism

As described above, the counting mechanism according to the currentinvention may further comprise a lockout mechanism configured to lockthe device at the end of its lifetime.

Generally speaking, the lock out mechanism according to the presentinvention may be employed in any counting device which comprises: afirst housing part 210; a second housing part 220 rotatable with respectto the first housing part 210; and a rotatable counting part 230;wherein rotation of the counting part 230 is driven by rotation of thesecond housing part 220 such that a full rotation of the second housing220 part produces an incremental rotation of the counting part 230 withrespect to the first housing part 210. FIGS. 11A to 11D schematicallyillustrate this general structure which is used by the various examplesof counting device according to the present invention described above.In FIG. 11 the first housing part 210 is rotatable relative to thesecond housing part 220 and a full rotation of these housing partsproduces an incremental rotational displacement between the rotatablecounting part 230 and the second housing part 220.

The mechanism by which the incremental rotation of the counting part 230is driven by rotation of the first housing part 210 may be by means of aradial protrusion driving a rolling motion of the counting part 230against the second housing part 220, as is described in the aboveexamples. However it may equally be by any other mechanism whichproduces an incremental rotation in the counting ring 230 (relative tothe second housing part 220) for every rotation of the first housingpart 210 (relative to the second housing part 220). For exampleconventional known gearing systems may equally be used to provide thereduction ratio between the rotations of these respective parts.

Each of the first housing part 210, second housing part 220 and countingpart 230 has a locking feature 211, 221, 231 positioned on the part sothat it rotates with the part. Considering the second housing part 220as a fixed reference, the locking feature 211 of the first housing part210 rotates past the locking feature 221 of the second housing part onceevery rotation of the first housing part 210 and the locking feature 231of the counting part 230 rotates past the locking feature 221 of thesecond housing part once every rotation of the counting part 230.

The locking features 211, 221, 231 are configured to engage and locktogether only when they are all simultaneously aligned as shown in FIG.11D. The use of the term “aligned” does not imply adjacency, just thatall three of the features are in the unique position in which theyinteract to lock-out. The locking together of the features prevents thefurther rotation of the housing parts. The first housing part 210rotates multiple times (n times) over the lifetime of the device whereasthe counting part 230 rotates only once. Of the three possible pairs ofthese parts, the first housing/counting part locking features and thefirst/second housing part locking features align multiple timesthroughout the life of the counter (n−1 and n, respectively), as shownin FIGS. 11B and 11C. The lockout must not trigger in these cases butonly when all three of the parts are aligned as shown in FIG. 11D.

The relative position of features 231 and 221 determines how many countsuntil the device locks out. The relative position of features 211 and221 determines at what point within the final revolution locking outoccurs and can therefore be used to specify the most logical positionfor a lock out within a final dose. For a device with multiple doses ina single revolution, there can be multiple 211 features, eachcorresponding to a single dose. The advantage of only having a single211 feature is that this decreases the tolerance sensitivity on feature231.

The locking features 211, 221, 231 may take any form appropriate toprovide the required locking of the first housing part, second housingpart and counting part upon simultaneous alignment of the features.FIGS. 12A to 12C schematically illustrate one example of the lock outmechanism, as employed in the counting mechanism according to thepresent invention, described above with reference to FIGS. 1 to 4. Inthis example the locking feature 221 provided on the second housing partcomprises a sprung member formed by a rod 222 and spring 223. The rod222 lies along the elongate axis P-P of the mechanism and is held underthe elastic tension of the spring 223 which is biased so as to apply aforce to the rod 222 along the axis P-P towards the first housing part110.

The locking features of the first housing part 110 and counting part 130each comprise an axially directed slot which are both shaped so as toreceive the rod 222. As shown in FIG. 12C, the end of the rod 222 has astepped-shape and is staggered in length such that a first end face 224contacts the axial end face 117 of the first housing part portion 112and a longer section has an end face 225 which contacts an axial endface 137 of the counting ring. Since the counting ring 130 has a greaterdiameter than the first housing part portion 112, when assembled thecounting ring axial end face 137 extends radially beyond the axial endface 117 of the first housing part 110. The two offset end faces 117,137 of the first housing part 110 and the counting ring 130 thereforemeet the staggered end faces of the rod and prevent the movement of therod, holding it in a primed position under the tension of the spring223.

As described above, the first housing part 110 rotates many times duringthe life time of the device such that the locking feature slot 211 ofthe first housing part will rotate under the rod 222. However since therod 222 remains supported at its end face 225 by the top axial end face137 of the counting ring 130, the rod 222 is not permitted to move intothe slot 211 under the action of the spring 223. It is only after asufficient number of rotations of the housing parts 110, 120 to drivethe counting ring 130 through sufficient incremental rotations to alignboth slots 211, 231 under the rod 222, that the rod is driven into bothslots 211, 231 under the action of the spring to trigger the lockout.

The sprung member is driven into the slots orthogonally to the directionof rotation of the housings. This effectively locks the first housing,second housing and counting ring together which, when applied in adispenser, prevents the user from dispensing more doses. For example,the mechanism may have an end of life lockout which triggers after 70doses. In this case the slots only align once 70 doses have beendispensed.

Although in the above example the locking features are provided by asprung feature and two slots, the slots can equally be replaced withraised posts. Furthermore the locking features may take any other formsuitable to lock the three rotatable parts together upon simultaneousalignment of the features.

The counting mechanism according to the present invention has a numberof advantages. Firstly the mechanism provides a large reduction ratiobetween a rotation of housing parts to a incremental rotationaldisplacement of a counting ring such that a record of a large number ofrotations can be kept. Importantly, the arrangement of the mechanismallows this to be achieved in a compact form. Since the movement of thecounting part is via rolling movement, the mechanism has greatly reducedwear and therefore an improved lifetime and resistance to failure of theparts. This allows means that the device operates with very littlenoise.

The counting mechanism according to the present invention only requiresthree parts and therefore is low cost and easy to manufacture andassemble. In particular the number of part changes between devices withdifferent counts can be minimised through design. For instance, whendesigning a device with both a 35:1 to and a 70:1 counting variant, the35:1 dose counter could be designed to have 72 teeth on the upperhousing and 70 on the counting ring and the 70:1 dose counter could bedesigned to have 71 teeth on the upper housing and 70 on the countingring. This way, the moulding for the counting ring does not have tochange between variants.

Due to the mechanical advantage provided by the system, any frictionwithin the counting mechanism is easily overcome by the user andtransmitted forces are low so the parts can be cheaply moulded out ofplastic. All parts can be moulded with a single line of draw and partassembly is largely axisymmetric. Since the counter is held in place bythe upper and lower housing it does not require additional retainingfeatures. The perimeter of the counting ring has more space availablethan the corresponding linear distance, so there is more room toindicate each increment. It is also easy to design a new counter with adifferent gearing ratio, simply by a change in the number of teeth.

The mechanism according to the present invention is furthermore highlyaccurate and has very little backlash. The counting mechanism is alsoresilient to shocks, particularly when teeth are included in the device,since some teeth are always meshed. It is also advantageous that theparts may have integrally formed teeth on their outside or insidesurfaces since there is no cost to forming these teeth as they may beformed when the parts are being cored out.

The lock-out mechanism according to the present invention provides asimple means to prevent a three part rotatable counting mechanism fromcontinued rotation after a predetermined number of rotations of theconstituent housing parts. Since the rotation of the counting mechanismis geared down from the rotation of the housing parts, the three partsonly align once during the lifetime of the device and this may be usedto initialise lockout. The simplicity of the mechanism means it isstraightforward and low cost to manufacture and the possibility offailure is reduced. The possibility of introducing a sprung featurewhich is driven orthogonally to the direction of rotation means theparts are tightly locked and cannot be easily overcome by applying aforce to rotate the housing parts.

1. An inhaler device for dispensing multiple doses, the inhaler devicecomprising: a first housing part; a second housing part rotatable withrespect to the first housing part; a rotatable first counting part; anda first lock provided on the first housing part, a second lock providedon the second housing part, and a third lock provided on the firstcounting part, wherein the first lock, the second lock, and the thirdlock are configured to lock together when all are simultaneouslyaligned; wherein after a predetermined number of rotations of the secondhousing part with respect to the first housing part, the first lock, thesecond lock, and the third lock are driven into alignment to preventfurther rotation of the second housing part with respect to the firsthousing part.
 2. The inhaler device of claim 1, wherein rotation of thefirst counting part is driven by rotation of the second housing partsuch that a full rotation of the second housing part produces anincremental rotation of the first counting part with respect to thefirst housing part to record a count.
 3. The inhaler device of claim 1,wherein the second lock of the second housing part is configured toalign with the first lock of the first housing part once every fullrotation of the second housing part with respect to the first housingpart and the third lock of the first counting part is configured toalign with the first lock of the first housing part once every fullrotation of the first counting part with respect to the first housingpart.
 4. The inhaler device of claim 1, wherein the first lock of thefirst housing part and the second lock of the second housing part alignmultiple times before all the first lock, the second lock, and the thirdlock align to prevent further rotation of the second housing part withrespect to the first housing part.
 5. The inhaler device of claim 1,wherein at least one of the first lock, the second lock, or the thirdlock comprises a sprung member, which is triggered upon simultaneousalignment with the other two of the first lock, the second lock, and thethird lock.
 6. The inhaler device of claim 5, wherein the sprung memberis driven orthogonally to the direction of rotation of the first housingpart and the second housing part.
 7. The inhaler device of claim 1,wherein one of the first lock, the second lock, and the third lockcomprises a sprung member and the other two of the first lock, thesecond lock, and the third lock each comprise a slot; wherein the slotsand sprung member align after a predefined number of rotations uponwhich the sprung member is driven into the slots orthogonally to thedirection of rotation, locking the first housing part, the secondhousing part, and the first counting part together.
 8. The inhalerdevice of claim 1, wherein: the second housing part has a curvedcross-sectional shape; the first counting part comprises a counting ringdisposed between the first housing part and the second housing part; thefirst housing part comprises a protrusion which abuts the counting ring,holding a portion of the counting ring in contact with the secondhousing part; wherein relative rotation of the first housing part andthe second housing part causes the protrusion to slide against a surfaceof the counting ring to drive a rolling movement of the counting ringaround the circumference of the second housing part; such that apredefined rotation of the first housing part and the second housingpart produces an incremental rotational displacement between thecounting ring and the second housing part to record a count.
 9. Theinhaler device of claim 1, wherein the first counting part comprises acounting ring disposed between the first housing part and the secondhousing part, the inhaler device further comprising: a first array ofgear teeth provided around a circumference of the counting ring and asecond array of gear teeth provided around a circumference of the secondhousing part, the first array of gear teeth and the second array of gearteeth positioned on opposing surfaces, the number of teeth in the firstarray on the counting ring differing from the number of teeth in thesecond array on the second housing part; wherein the first housing partcomprises a protrusion which abuts the counting ring, holding a portionof the counting ring in contact with the second housing part such thatthe opposing teeth of the counting ring and the second housing part meshat the contacted portion; and relative rotation of the first housingpart and the second housing part causes the protrusion to slide againsta surface of the counting ring to drive a rolling movement of thecounting ring around the circumference of the second housing part, therolling movement of the counting ring against the second housing partcomprising a sequential interlocking of teeth of the counting ring withthose of the second housing part; such that a predefined rotation of thefirst housing part and second housing part produces an incrementalrotational displacement between the counting ring and the second housingpart due to the difference in number of teeth in the first array andsecond array.
 10. The inhaler device claim 9, wherein: the first housingpart is positioned at least partially within the second housing part,the counting ring disposed around the first housing part; the firstarray of teeth is provided on the inner surface of the second housingpart; the second array of teeth is provided on the outer surface of thecounting ring, the counting ring having less teeth than the secondhousing part; and the protrusion extends radially from the outer surfaceof the first housing part, the protrusion abutting the inner surface ofthe counting ring, displacing the counting ring off-axis to contact thesecond housing part; such that relative rotation of the first housingpart and the second housing part causes the protrusion to drive aneccentric rotation of the counting ring about the axis of the secondhousing part.
 11. The inhaler device of claim 9, wherein the secondhousing part is positioned at least partially within the first housingpart, the counting ring disposed around the second housing part; thefirst array of teeth is provided on the outer surface of the secondhousing part; the opposing array of teeth is provided on the innersurface of the counting ring, the counting ring having more teeth thanthe second housing part; and the protrusion extends radially from theinner surface of the first housing part, the protrusion abutting theouter surface of the counting ring, displacing the counting ringoff-axis to contact the second housing part; such that relative rotationof the first housing part and the second housing part causes theprotrusion to drive an eccentric rotation of the counting ring about theaxis of the second housing part.
 12. The inhaler device of claim 8,wherein: the first housing part has multiple protrusions; the countingring is flexible such that the protrusions abut the counting ringcausing it to deform and contact the second housing part at positionscorresponding to the protrusions; and relative rotation of the firsthousing part and the second housing part causes the deformation of thecounting ring to propagate around its circumference, driving asequential interlocking of teeth at the contact portions of the countingring and second housing part; wherein the incremental rotationaldisplacement between the counting ring and second housing part isprovided by the difference in number of teeth.
 13. The inhaler device ofclaim 8, wherein the opposing surfaces of the counting ring and thesecond housing part are high friction surfaces such that they produce anon-slip contact; wherein relative rotation of the first housing partand the second housing part causes the protrusion to drive a rolling,non-slip movement of the counting ring against the second housing part;and a difference in the circumference of the counting ring andcontacting surface of the second housing part produces the incrementalrotational displacement between the counting ring and the second housingpart.
 14. The inhaler device of claim 1, wherein the first housing partand the second housing part are coaxial.
 15. The inhaler device of claim1, wherein the second housing part is cylindrical.
 16. The inhalerdevice of claim 2, wherein the gearing ratio, providing the ratiobetween the predefined rotation of the first housing part and the secondhousing part and incremental rotational displacement of the countingring and second housing part, is between 3:1 and 300:1.
 17. The inhalerdevice of claim 2, further comprising: a second counting part configuredsuch that every complete rotation of the first counting part relative tothe second housing part produces an incremental rotational displacementbetween the second counting part and the second housing part.
 18. Theinhaler device of claim 1, wherein the predefined rotation of the firsthousing part and the second housing part is associated with a dispensingfunction, such that the rotational displacement of the first countingpart and the second housing part provides a record of the number ofdoses dispensed.
 19. The inhaler device of claim 1 further comprising: aratchet provided on one of the first housing part or the second housingpart; and a pawl provided on the other of the first housing part and thesecond housing part; such that only one direction of relative rotationis permitted by the first housing part and the second housing part. 20.The inhaler device of claim 2, wherein the first housing part and thesecond housing part are coaxial.